Sterile Disposable PN Drape System
by Brant-Wald Surgicals, Inc. 510(k)
Active
510(k) K850912
Overview
The Sterile Disposable PN Drape System is a surgical drape designed to limit contamination of the surgical wound, surgical instruments, and the surgeon's hands during operative procedures. It functions as a sterile barrier to maintain aseptic conditions in the surgical field.
This device is supplied sterile and intended for single-use disposal after each procedure. It is regulated under FDA 510(k) clearance K850912 and classified under product code KKX. The device does not include an antimicrobial agent and is used in general and plastic surgery settings as indicated by its advisory committee classification.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK850912 | Date3 May 1985 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- KKX
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4370
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Other devices from Brant-Wald Surgicals, Inc.
Questions
What is the Sterile Disposable PN Drape System used for?
It is designed to limit contamination of the surgical wound, instruments, and surgeon's hands during operative procedures by functioning as a sterile barrier to maintain aseptic conditions in the surgical field.
Is the Sterile Disposable PN Drape System sterile and intended for single use?
Yes, the device is supplied sterile and intended for single-use disposal after each procedure, as specified in its description, to ensure infection control and prevent cross-contamination between surgeries.
What regulatory pathway was used for the Sterile Disposable PN Drape System?
The device was regulated under FDA 510(k) clearance K850912, which indicates it was found substantially equivalent to a legally marketed predicate device through the traditional 510(k) review process.